Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05437380

Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-03-25

70

Participants Needed

1

Research Sites

196 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Cervical lymph node metastasis is frequently encounted on the date of diagnosis. Surgical resection is one of the most important treatment methods for head and neck squamous cell carcinoma with or without lymph node metastasis. At present, for cN0 patients, prophylactic neck dissection is recommended for squamous cell carcinoma originating in suprglottic, hypopharyngeal and oropharyngeal areas et al. Related studies reported that less than 30% of patients with cN0 were confirmed to have lymph node metastasis in postoperative pathological examination, who underwent neck dissection. Unnecessary neck dissection may increase complication incidence, such as neurovascular injury, chylous leakage, sialosyrinx. Accurate preoperative assessment is helpful to reduce unnecessary neck dissection. Sentinel lymph node biopsy were proved to be effective in reducing prophylactic lymph node dissection in breast cancer, melanoma and other malignant tumors. Compared with γ probe detection and indolyanine green injection, microbubble and contrast-enhanced ultrasound has no radiation and disturbance to resection margins in sentinel lymph nodes detection. Furthermore, surgeons could conduct lymph node puncture biopsy simultaneously under ultrasound guidance, which can further minimize surgical trauma. At present, the role of microbubble and contrast-enhanced ultrasound in sentinel lymph node detection and biopsy is rarely reported in head and neck squamous cell carcinoma. This study aims to explore the accuracy of peritumoral microbubbles and contrast-enhanced ultrasound for sentinel lymph nodes biopsy in predicting cervical lymph node metastasis in head and neck squamous cell carcinoma.

CONDITIONS

Official Title

Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-70
  • Confirmed head and neck squamous cell carcinoma by pathological biopsy
  • MR or CT shows no suspected cervical lymph node metastasis
  • Planned primary tumor removal and unilateral or bilateral neck dissection at the study center
  • Agree to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Allergy to microbubble contrast agents
  • Unable to tolerate surgery
  • Enlarged cervical lymph nodes on palpation or suspected metastasis on MR/CT
  • Presence of distant metastasis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

L

Lin Peiliang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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